Clinical Trial Essentials; Implementation Best Practice: Two-Day Intensive GCP Course

By: Amer Alghabban, Managing Director, GxP Compliance and Training Partners (GCTP)
Location :- Zurich, Switzerland | Wednesday, December 4, 2019 | Thursday, December 5, 2019

We need the below information to serve you better

Course Description:

This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP). Participants will acquire real-world application of GCP regulations and guidelines for critical elements of the clinical research and development process. This training includes the updates brought by the ICH E6 R2 Addendum.

During this interactive workshop, we will debate in what way clinical research team members can apply systems to achieve data integrity and quality through the trial lifecycle.

Specific attention will be given to how quality systems affect overall data integrity, patient clinical risk, and respective regulatory risk.

Learning Objectives:

  • Describe the elements of functional Quality Systems for Sponsors, Institutional Review Boards (IRBs), and Clinical Investigators
  • Identify the universal and local components of GCP
  • Explain the differences between the legal and procedural elements of GCP
  • Describe the overlap between GCP and Good Manufacturing Practice (GMP)
  • Recognize key differences in pharmaceutical, device, and biologics GCP
  • Examine recent trends in non-compliance
  • Develop and implement site-specific approaches for corrective action of non-compliance

Areas Covered:

  1. Principles of GCP: Different Perspectives: Examination; application; implementation
  2. New Developments and Emerging Trends in GCP
  3. The “Forgotten” Elements of GCP: Regulations; laws; guidelines
  4. Quality Systems: The Roadmap to GCP: Quality control; quality assurance; quality improvement
  5. Quality Risk Management (QRM) in Clinical Trials: Application of risk assessment in the review of protocols
  6. The Role of Standard Operating Procedures in GCP: Rationale; development; training; implementation; maintenance
  7. GCP Across Investigational Products: Drugs; devices; biologics
  8. Are We There Yet? Recent non-compliance issues with discussion of Corrective and Preventive Action planning

Who will Benefit:

This program is designed for professionals with two to three years of experience in the clinical research industry. Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP Focused Regulatory Affairs Professionals.

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.30 AM - 09.00 AM - Registration, Meet and Greet.
  • 09.00 AM - Session Start Time
  • Historical overview of Clinical Research
  • Observational studies
    • Case report
    • Case series
    • Cross section studies
    • Case control studies
    • Cohort studies
  • Phases of Clinical Development & Types of Clinical Trials
  • Planning and Initiating a Clinical Trial:
    • Role of the Sponsor:
      • Quality Assurance (QA) (see allocated time)
      • Contract Research Organizations (CROs)
      • Trial / Protocol Design
      • Trial Conduct & Management
      • Investigator Selection: Who can be an Investigator?
      • Sponsor Monitoring (See allocated time below)
  • Lunch Break
  • Ethics & Research Subject Protection
    • History of research ethics
    • Human Subject protection
    • Risk assessment
  • Investigator Responsibilities:
    • Qualifications & Agreements
    • Resources & Selection of the trial team: delegation, Log of study Personnel, Keeping members informed
    • Medical Care of trial subjects
    • Compliance with the protocol
  • Quality Assurance / Quality Control in Clinical Trials
    • Defining the terminology
    • The quality challenges
    • The quality plan / Operational QC
    • Role of Clinical Quality Assurance: What should you expect from Clinical Quality Assurance (CQA)?
    • GCP Audits: what you need to know
  • Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management
    • What is non-compliance?
    • Most common inspection & audit findings
    • Identifying the root cause
    • Corrective Action versus Preventative Action
    • What is NOT a good CAPA?
  • Ethics for Genetics Research
  • Informed Consent: The how? What? & why?
  • Investigational Medicinal Product & Drug Accountability
  • Safety Reporting:
    • Protocol requirements pertaining to safety
    • Expedited reporting of adverse events (AEs).
    • What makes a well-documented adverse event (AE).
    • What is a Suspected Unexpected Adverse Reaction (SUSAR).
    • Laboratory Evaluations
  • Day Two (8:30 AM – 4:30 PM)
  • 09.00 AM - Session Start Time
  • Drug Safety Monitoring Board (DSMB)/Independent Drug Monitoring Committee (IDMC) Clinical Trial Safety and Safety Monitoring
    • Background & GCP Guidelines for DSMB/IDMC
    • What are the processes of DSMB/IDMC Review?
  • Sharing Best Practice in Patient Recruitment & Subject retention
    • Subject Recruitment:
    • Recruitment prediction,
    • Advertising,
    • Avoiding pitfalls.
  • Lunch Break
  • Essential Documents To Ensure A Complete TMF Under All Regulations
    • Regulators’ Focus on TMF: Why?
    • Why should sponsors Focus on TMF?
    • Common Audit/Inspection TMF-related findings
    • Lessons learnt………. Or…. Not!
  • Data Quality and Archive
  • Meet Your Instructor

    Amer Alghabban
    Amer Alghabban
    Managing Director, GxP Compliance and Training Partners (GCTP)

    Amer Alghabban, M.Sc. (Clin. Pharmacology), Post-Grad. Cert. Clinical Research, Dipl. Bio. Sci., B.Sc., Cert. Teacher Education, M Soc. Pharm. Med., MRQA, MIQA, MDIA, ISO 9001:2015 QMS Certified Lead Auditor, IRCA Certified Lead Auditor.

    Amer is currently the Managing Director of GxP Compliance and Training Partners (GCTP), which he founded, helping pharmaceutical companies & academic institutions worldwide to achieve compliance with GCP, GVP, GCLP, GDP and GLP.

    Amer, a Clinical pharmacologist by education, has over 28 years’ experience in the pharmaceutical industry. He enjoys imparting his experiences, as an invited speaker at over 125 international congresses and as writer; he published 2 reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. Amer has experience of working at the MHRA where he participated in the conduct of the very first Regulatory Authority pharmacovigilance-GCP inspection in the EU and wrote the 1st EU regulatory authority SOPs on conducting GVP inspections. He has over 21 years’ experience of directing Inspection Readiness Programs (Mock Inspections & Pre- & Post-Mock Inspection-Training) and hosting regulatory authorities’ & notified bodies’ inspections. To date, he has prepared, trained, hosted & managed over 67 Regulatory Authorities’ inspections by all major regulatory authorities (FDA, EMA, EU Authorities (CAs), Japanese PMDA, Brazilian, Chinese SFDA & Middle Eastern authorities etc.) Earlier in his career, he was Assistant Editor for 11 medical journals and was the 1st invited Course Director for The Pharmacovigilance Auditing Course at the RQA.

    Amer’s other previous positions included: Vice President GxP Quality Assurance, Compliance & Training at Karyopharm Therapeutics Inc. Boston, USA, Global Director, Head of Quality Assurance at Merck Serono, Geneva, Switzerland, Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.

    Venue

    Location:
    Zurich, Switzerland (Venue to be announced shortly)

    December 4-5, 2019
    Register Online

    Register Online

    $1,699

    Seminar One Registration (USD)

    December 4-5, 2019, Zurich, Switzerland
    (Registrations till September 30, 2019 - $1699)
    (Registrations after September 30, 2019 - $1899)

    Early bird seats are limited and based on first-come, first-serve.

    The registration fee includes: the workshop; all related course materials; morning tea/coffee on both days.
    For discounts on multiple registrations, contact customer care at +1-1-888-771-6965 .

    Register by Wire Transfer

    If you wish to pay by wire transfer: Please call us at
    Toll Free +1-1-888-771-6965


    Download Registration Form

    Yes, I want to attend "Clinical Trial Essentials; Implementation Best Practice: Two-Day Intensive GCP Course"
    Click here to Download Registration Form
    If you are paying by check:
    Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
    2600 E. Bayshore Road
    Palo Alto, CA 94303
    USA

    Terms & Conditions to register for the Seminar/Conference/Event

    Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ editor@grcseminars.com

    Payment:

    Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

    Cancellations and Substitutions:

    Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

    On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

    Substitutions may be made at any time. No-shows will be charged the full amount.

    We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

    In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

    Attendance confirmation and Documents to carry to the seminar venue:

    After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

    Conference photograph / video:

    By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

    Media Partners

    If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
    Media Partner Benefits
    • Logo and company data on the event website.
    • Logo on the conference material distributed during the conference.
    • Media Partner’s brochure distributed along with conference material.
    • Logo on all the mailings before and after the event.
    • 10% discount to media partner's subscribers.
    Media Partner to do
    • Banner (min 728x90 or 468x60) on the Media Partner website.
    • Insertion of the event in the event calendar, both printed and/or online.
    • Announcement article of the conference on the Magazine and/or Website.
    • Dedicated email blast to all subscribers of Media Partner.
    • Article on the Magazine and/or Website after the conference.

    Local Attractions of Zurich, Switzerland

    Kunsthaus Zurich
    The Kunsthaus is Zurich's most important art museum and one of the most famous in Europe. Although the collection of the Kunsthaus Zürich ranges from Ancient times to the Victorian Era, the Swiss art museum is most noted for its modern and contemporary works from the 19th and 20th centuries. Top exhibits include the Giacometti wing and Rodin's Gate of Hell.

    Bahnhofstrasse
    Widely known as the principal boulevard in Zürich, the Bahnhofstrasse is Zurich's most famous shopping street. Lined with some of the city's most elegant boutiques and top department stores, the Bahnhofstrasse offers a delightful place for a day of shopping amongst some of the world's greatest luxury brands and jewelry stores.


    Zurich Zoo
    Elephants, rhinos, tigers, penguins and 20 species of monkeys are just some of the more than 360 animal species that can be admired at the Zurich Zoo. In the Masoala Rainforest Hall visitors can experience a piece of Madagascar first hand. A must-see for young and old.


    Limmat River
    Switzerland's Limmat River is actually part of the Linth river, which continues from Lake Zurich. Zurich is the most famous city located along the Limmat Valley and the Limmat River provides a charming and beautiful waterway to explore the sights of Zurich by boat.


    Fraumunster Church
    The Fraumünster Church overlooks one of Zurich's oldest squares and markets, the Münsterhof. Tracing its founding back to 853, when it was a Benedictine abbey, the church is home to five famous stained-glass windows by renowned artist Marc Chagall.

    Zurich Old Town
    Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings


    Schweizerisches Landesmuseum
    The Schweizerisches Landesmuseum (or Swiss National Museum in English) occupies an imposing neo-Gothic building, which houses a huge collection of objects documenting the Swiss peoples and their history. The collections range in date from prehistoric to modern times.